TenNor Therapeutics Suzhou Ltd.

SUZHOU, China, Nov 18, 2024 /PRNewswire/ -- TenNor Therapeutics, a clinical-stage company dedicated to developing novel therapies to address unmet needs in infectious diseases, announced today the successful completion of a phase III clinical trial of rifasutenizol (TNP-2198) for the treatment of Helicobacter pylori (H. pylori) infection. The study met its primary endpoints, showing multiple advantages of rifasutenizol regimen compared with bismuth-containing quadruple therapy (BQT), the current standard of care. The completed study is a multicenter, randomized, double-blind, controlled phase III clinical trial to evaluate the efficacy and safety of TNP-2198 in combination with amoxicillin and rabeprazole for the treatment of H. pylori infection in treatment-naive patients. The study was conducted in 40 hospitals in China. A total of 700 treatment-naive patients with H. pylori infection confirmed by a positive carbon-13 urea breath test (C-13 UBT) and histological examination were randomly assigned in a 1:1 ratio to receive rifasutenizol triple therapy (rifasutenizol 400 mg, amoxicillin 1 g and rabeprazole 20 mg) or BQT (bismuth potassium citrate 240 mg, clarithromycin 500 mg, amoxicillin 1 g and rabeprazole 20 mg) treatment, twice a day for 14 days. The efficacy endpoint was the C-13 UBT test result 4 to 6 weeks after the end of treatment. Patient compliance was high in the study with a low dropout rate of 3%. H. pylori was successfully cultured in 87% patients. There were no significant differences in demographics or baseline antibiotic resistance characteristics between the two treatment groups that could affect the study outcomes. Resistance rates to clarithromycin, metronidazole, levofloxacin and amoxicillin among H. pylori clinical isolates from this study were 41%, 68%, 35% and 8% respectively, which are consistent with data reported recently by other studies, indicating antibiotic resistance to H. pylori is a serious problem in China. All clinical isolates from the study were susceptible to rifasutenizol. Rifasutenizol triple therapy achieved >90% eradication rate in the modified intention-to-treat (mITT) population, higher than BQT control (92.0% vs. 87.9%, difference 4.1%, non-inferiority test p<0.0001, superiority test p= 0.0338). The rifasutenizol regimen also achieved a higher eradication rate than BQT in the per protocol (PP) population (93.7% vs. 90.3%, difference 3.4%, non-inferiority test p<0.0001, superiority test p=0.0563). In patients infected with H. pylori resistant to any of the current antibiotics, rifasutenizol triple therapy also achieved a higher eradication rate than BQT (90.9% vs. 87.2%, difference 3.7%, non-inferiority test p<0.0001), indicating rifasutenizol regimen is highly effective in patients with antibiotic-resistant H. pylori infections. Rifasutenizol regimen showed better safety and tolerability profile than BQT. The treatment-emergent adverse events (TEAEs), investigational drug related TEAEs, TEAEs with grade 3 or above are all lower in the rifasutenizol arm. Most TEAEs were Grade 1 and no investigational drug related serious adverse events (SAEs) reported. Rifasutenizol is a novel multi-targeting drug candidate with a synergistic mechanism of action against anaerobic and microaerophile bacteria. It has potential to become the first new drug developed specifically for H. pylori infection in more than 30 years. Rifasutenizol could play an important role in supporting the large-scale test-and-treatment strategy to prevent gastric cancers in populations with high gastric cancer risk, as the rifasutenizol regimen does not require drug sensitivity test and can be seamlessly integrated with the UBT testing. TenNor completed 7 phase I-III clinical trials in China and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA). About TenNor Therapeutics TenNor Therapeutics is a clinical-stage company specialized in the discovery and development of differentiated new drug products for diseases associated with bacterial infection and metabolism. TenNor possesses a unique multi-targeting drug conjugate technology and a strong new drug development portfolio with global IP protection. Several products are currently in late-stage of clinical development targeting H. pylori infection, medical device infections, hepatic encephalopathy and irritable bowel syndrome with diarrhea. The company is committed to address unmet needs in the disease area and provide safe and effective therapies for patients in China and around the world. For more information please visit: . SOURCE TenNor Therapeutics (Suzhou) Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Plus, news about TenNor Therapeutics, Gan & Lee Pharmaceuticals, Orasis and Optus Pharmaceuticals: Exscientia receives $15M milestone from Sanofi: The companies are advancing two programs as part of a deal first announced in 2022. Exscientia said it’s now eligible for additional milestones worth more than $600 million, in addition to royalties. — Jaimy Lee Eli Lilly brings Gateway Labs to China: The drugmaker is launching one of its Gateway Labs in China, the company said Tuesday, the day after announcing plans to open one in the UK. Lilly also said it’s opening a research hub in Beijing called the Lilly China Medical Innovation Center. — Anna Brown TenNor raises more than $42M in Series E: The Chinese company plans to use the funds to support the development and potential approval in China of rifasutenizol, its candidate for Helicobacter pylori infection. AMR Action Fund chipped in as a new investor, alongside existing supporters such as Zhongshan Venture Capital. — Ayisha Sharma Gan & Lee’s trio of diabetes drugs passes mid-stage trials: The Beijing-based biotech unveiled promising blood sugar data from its GLP-1 agonist (GZR18), once-weekly insulin analog (GZR4) and premixed dual insulin analog (GZR101) from their respective mid-stage studies. Notably, the GLP-1 agonist showed greater reductions in HbA1c and body weight than Novo Nordisk’s semaglutide. — Ayisha Sharma Orasis signs licensing deal with Korean drugmaker: Optus is paying $18 million to commercialize, import and market Qlosi, an eye drop for presbyopia, in South Korea. It plans to launch the treatment there by 2026. — Jaimy Lee

SUZHOU, China, Oct. 16, 2024 /PRNewswire/ -- TenNor Therapeutics, a clinical stage company dedicated to developing new therapies to address unmet needs in infectious diseases, announced today the initial closing of a Series E financing round for more than 300 million RMB. New investor AMR Action Fund joined Zhongshan Venture Capital and other existing investors in the round. The proceeds will be used to support the development and to seek regulatory approval in China of rifasutenizol, which could become the first new drug developed specifically for Helicobacter pylori infection in more than 30 years. "We are extremely glad to have the financial support from AMR Action Fund, Zhongshan Venture Capital, and other existing investors," said Dr. Zhenkun Ma, Founder and CEO of TenNor Therapeutics. "TenNor is dedicated to addressing the challenges of drug-resistant infections in China and around the world by innovating solutions for diseases currently without adequate therapies. With the additional funding, TenNor is well positioned to seek regulatory approval and bring to market rifasutenizol, a novel therapy for Helicobacter pylori infections, while also advancing a second product that will target prosthetic joint infections and similar infections associated with medical devices." "The global burden of drug-resistant bacterial infections is staggering and only getting worse, with recent data in The Lancet indicating that nearly 40 million people will die from antimicrobial resistance by 2050," said AMR Action Fund Chief Executive Officer Henry Skinnner, PhD. "We are pleased to support the team at TenNor as they advance the development of novel antibiotics that could save the lives of patients around the world and significantly reduce the suffering associated with these intractable infections." "TenNor is a leading company with multiple assets in late-stage of clinical development for the treatment of diseases associated with bacterial infections and metabolism," said Cheng Zhang, Chairman of Zhongshan Venture Capital, "TenNor adopts a first-line strategy to address major unmet needs in China. The products TenNor is developing has significant market potential in China and around the world. We are very glad to support this round of investment together with AMR Action Fund, a global leader in the antimicrobial space." TenNor develops differentiated products for diseases associated with bacterial infections and metabolism that currently lack adequate therapeutic options. The company adopts a business strategy to develop first-line therapies for indications with clear unmet medical needs and major market potential to ensure commercial success. TNP-2198 (rifasutenizol) is a novel multi-targeting drug candidate with a synergistic mechanism of action against anaerobic and microaerophile bacteria. It has potential to become the first new drug developed specifically for Helicobacter pylori infection in more than 30 years. TNP-2198 could play an important role in supporting the large-scale screening-and-eradication strategy to prevent gastric cancers in regions with high gastric cancer rate. TenNor is completing a phase 3 clinical trial of TNP-2198 in China and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA). TNP-2092 (rifaquizinone) is a novel triple targeting drug candidate designed to address the dual challenges of antimicrobial resistance and persistence associated with medical device infections. TenNor has completed six phase 1 and phase 2 clinical trials for TNP-2092 for injection and is planning for a phase 3 multiregional clinical trial for the treatment of prosthetic joint infections. TNP-2092 has received QIDP, Fast Track and Orphan Drug designations from the U.S. FDA. About TenNor Therapeutics TenNor Therapeutics is a clinical-stage company specialized in the discovery and development of differentiated new drug products against diseases associated with bacterial infection and metabolism. TenNor possesses a unique multi-targeting drug conjugate technology platform and a strong new drug development portfolio with global IP protection. Several products are currently in late-stage of clinical development targeting H. pylori infection, medical device infections, hepatic encephalopathy and irritable bowel syndrome with diarrhea. The company is committed to address the unmet needs in the disease area and provide safe and effective therapies for patients in China and around the world. For more information please visit: . SOURCE TenNor Therapeutics (Suzhou) Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED